Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT02840422
• Lead Sponsor: LCA Pharmaceutical

Brief Summary

The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.

This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.

This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.

Detailed Description

Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)

Study Timeline

• Study Start: 2016-02-03
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Primary Completion: 2016-12-08
• Study Completion: 2017-07-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Men or women aged over 40;
• Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale
• Patient able to understand the trial procedure and give his/her consent to take part, in writing;
• Patient geographically stable during the trial;
• Patient affiliated to the French social security regime or benefiting from such a French regime.

Exclusion Criteria

• Inflammatory arthritis;
• Progressive infectious condition of the knee being studied;
• Previous treatment with viscosupplementation for at least one year;
• Injection of corticoids into the knee studied for less than two months;
• Known hypersensivity to hyaluronic acid or substances with similar activity;
• Pregnant or breast-feeding women;
• Patient under guardianship or tutorship or under juridicial protection;
• Patient currently taking part in another clinical research study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial)	6 months

Secondary Outcome Measures

Name	Time	Method
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)	6 months	* From D0 to D90; * From D90 to D180
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)	6 months	* From D0 to D90; * From D0 to D180; * From D90 to D180
To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)	6 months	* From D0 to D90; * From D0 to D180; * From D90 to D180